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Clinical Trials/NCT04262011
NCT04262011
Unknown
Not Applicable

Effect of Non-surgical Periodontal Treatment on Renal Function and C-reactive Protein Levels in Hemodialysis Patients

Universidade Federal de Santa Maria1 site in 1 country88 target enrollmentFebruary 29, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Disease Stage 5
Sponsor
Universidade Federal de Santa Maria
Enrollment
88
Locations
1
Primary Endpoint
effect of periodontal treatment on levels of systemic inflammatory markers
Last Updated
6 years ago

Overview

Brief Summary

The presence of periodontitis has been hypothesized as a risk factor for several systemic outcomes, including chronic kidney disease (CKD). Therefore, the aim of this study is to evaluate the impact of non-surgical periodontal treatment on CRP levels and quality of life of patients with chronic kidney disease undergoing hemodialysis (HD) in Santa Maria-RS.

Detailed Description

C-reactive protein (CRP) has been identified as a possible mediator of the association between periodontitis and various systemic diseases. The presence of periodontitis has been hypothesized as a risk factor for several systemic outcomes, including chronic kidney disease (CKD). Therefore, the aim of this study is to evaluate the impact of non-surgical periodontal treatment on CRP levels and quality of life of patients with chronic kidney disease undergoing hemodialysis (HD) in Santa Maria-RS. A total of 88 patients with severe periodontitis who are on HD therapy will be included in this study. At baseline, periodontal, radiographic, blood test, and quality-of-life questionnaire will be assessed for all patients, after which severe periodontitis will be defined according to the American Association of Periodontology and European Federation of Periodontology. The 88 patients with periodontal disease will be randomized and divided into two groups. One group will receive full mouth non-surgical periodontal treatment (TPNC) and a late treatment group that will receive TPNC only at the end of the study. All patients will receive follow-up of periodontal parameters and blood collection for initial CRP assessment at 3 and 6 months after treatment. Outcome evaluators will be blind to the group the patient belongs to. Patients in the immediate treatment group will receive follow-up oral hygiene instructions and use 0.12% chlorhexidine mouthwash during the first week after treatment.

Registry
clinicaltrials.gov
Start Date
February 29, 2020
End Date
June 1, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fabricio Batistin Zanatta

Principal advisor

Universidade Federal de Santa Maria

Eligibility Criteria

Inclusion Criteria

  • Having been diagnosed with chronic kidney disease (CKD) for at least 90 days.
  • Have at least 8 teeth in the mouth.
  • For the patient to be classified as having periodontal disease, he must have at least two nonadjacent sites with insertion loss of 3mm or more and two nonadjacent sites with probing depth of 4mm or more.

Exclusion Criteria

  • Ineligible individuals were characterized by exhibiting one of the following conditions:
  • Patients diagnosed with malignant neoplasia;
  • Patients diagnosed with carriers of the HIV virus;
  • Pregnant or lactating women;
  • Patients with absence of all dental elements (total edentulous);
  • Patients undergoing orthodontic treatment;
  • Patients who have received periodontal treatment in the last 6 months.
  • Patients with active infection (other than periodontitis) who require antibiotic prophylaxis;

Outcomes

Primary Outcomes

effect of periodontal treatment on levels of systemic inflammatory markers

Time Frame: baseline changes by 6 months follow-up

To evaluate the impacts of periodontal treatment on the levels of systemic inflammatory markers such as C-reactive protein, albumin and transferrin saturation. The patients will be submitted to the collection of blood sample in the baseline, 3 and 6 months to obtain the clinical variables.

Secondary Outcomes

  • effect of periodontal treatment on overall quality of life and related to kidney disease(baseline changes by 6 months follow-up)
  • effect of periodontal treatment on overall quality of life(baseline changes by 6 months follow-up)
  • effect of periodontal treatment on psychological condition in patients with chronic kidney disease undergoing hemodialysis(baseline changes by 6 months follow-up)
  • effect of periodontal treatment on psychological condition(baseline changes by 6 months follow-up)
  • effect of periodontal treatment on oral health-related quality of life(baseline changes by 6 months follow-up)

Study Sites (1)

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